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Kinematics of Obese Patients Perambulation (MARCHOBESE)

Primary Purpose

Morbid Obesity, Surgical Management by Laparoscopic Sleeve Gastrectomy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
6-minute walk test
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring obesity, surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI between 40 and 60 kg/m2 or BMI > 35 kg/m2 with at least one comorbidity
  • no weight loss
  • between 18 and 65 years old
  • history of obesity > 5 ans

Exclusion Criteria:

  • history of bariatric surgery
  • major cardiac insufficiency
  • pregnancy or breastfeeding
  • no social welfare

Sites / Locations

  • Chu Amiens

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

6-minute walk test

Arm Description

the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist.

Outcomes

Primary Outcome Measures

6-minute walk test
the value of this test is obtained by the difference between the 6-minute walk test performed before the surgery and the 6-minute walk test performed 6 months after the surgery

Secondary Outcome Measures

quality of life
the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after.
BAROS score
the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
quality of life with the Mooreheald-Ardelt questionnaire
the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery

Full Information

First Posted
January 22, 2013
Last Updated
April 25, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01774682
Brief Title
Kinematics of Obese Patients Perambulation
Acronym
MARCHOBESE
Official Title
Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.
Detailed Description
Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients. Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Surgical Management by Laparoscopic Sleeve Gastrectomy
Keywords
obesity, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6-minute walk test
Arm Type
Other
Arm Description
the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist.
Intervention Type
Procedure
Intervention Name(s)
6-minute walk test
Intervention Description
the test corresponds to that defined by Abdel Kafi et al in 2005
Primary Outcome Measure Information:
Title
6-minute walk test
Description
the value of this test is obtained by the difference between the 6-minute walk test performed before the surgery and the 6-minute walk test performed 6 months after the surgery
Time Frame
6 months after the surgery
Secondary Outcome Measure Information:
Title
quality of life
Description
the quality of life is evaluated by the SF36 questionnaire which is performed before the surgery and 6 months after.
Time Frame
6 months after the surgery
Title
BAROS score
Description
the baros score is evaluated by the surgeon during the consultation 6 months after the surgery
Time Frame
6 months after the surgery
Title
quality of life with the Mooreheald-Ardelt questionnaire
Description
the Mooreheald-Ardelt questionnaire is completed by the patient during the consultation 6 months after the surgery
Time Frame
6 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI between 40 and 60 kg/m2 or BMI > 35 kg/m2 with at least one comorbidity no weight loss between 18 and 65 years old history of obesity > 5 ans Exclusion Criteria: history of bariatric surgery major cardiac insufficiency pregnancy or breastfeeding no social welfare
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdennaceur dhahri, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23001573
Citation
Rebibo L, Fuks D, Verhaeghe P, Deguines JB, Dhahri A, Regimbeau JM. Repeat sleeve gastrectomy compared with primary sleeve gastrectomy: a single-center, matched case study. Obes Surg. 2012 Dec;22(12):1909-15. doi: 10.1007/s11695-012-0779-9.
Results Reference
background
PubMed Identifier
22884227
Citation
Rebibo L, Dhahri A, Verhaeghe P, Regimbeau JM. Early gastric fistula after laparoscopic sleeve gastrectomy: surgical management. J Visc Surg. 2012 Oct;149(5):e319-24. doi: 10.1016/j.jviscsurg.2012.07.004. Epub 2012 Aug 9. No abstract available.
Results Reference
background
PubMed Identifier
22809752
Citation
Pequignot A, Dhahri A, Verhaeghe P, Desailloud R, Lalau JD, Regimbeau JM. Efficiency of laparoscopic sleeve gastrectomy on metabolic syndrome disorders: two years results. J Visc Surg. 2012 Oct;149(5):e350-5. doi: 10.1016/j.jviscsurg.2012.06.005. Epub 2012 Jul 17.
Results Reference
background
PubMed Identifier
22790710
Citation
Rebibo L, Mensah E, Verhaeghe P, Dhahri A, Cosse C, Diouf M, Regimbeau JM. Simultaneous gastric band removal and sleeve gastrectomy: a comparison with front-line sleeve gastrectomy. Obes Surg. 2012 Sep;22(9):1420-6. doi: 10.1007/s11695-012-0689-x.
Results Reference
background
PubMed Identifier
20971049
Citation
Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
Results Reference
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Kinematics of Obese Patients Perambulation

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